Compounding Pharmacy Problems

Compounding pharmacies have been in the news a lot lately and much of the news is disturbing. There are reports of mold actively growing in IV bags, pre-filled syringes contaminated with fungus and a host of other life-threatening mistakes by compound pharmacies.

The Merman Law Firm is on the forefront of the compounding pharmacy problems and represents victims from coast to coast. If you suspect that you or a loved one have been a victim of contaminated compounded drugs, contact us immediately for compassionate representation.

What is compounding?

Some medical patients need the benefits of a Food and Drug Administration (FDA)-approved drug but are unable to take the drug due to its form, contents or composition. Pharmacy compounding is a practice in which an FDA-approved drug is altered by a licensed pharmacist to fill a prescription tailored to meet the special needs of a patient. The process can involve some of the following situations: combining two or more drugs into one, reformulating a drug to eliminate an ingredient a patient is allergic to or changing a drug’s form from a pill to a liquid. Thus, pharmacy compounding provides an invaluable service to medical patients that have special prescription needs.

When do problems arise?

The value in pharmacy compounding is realized when compounders perform their traditional role: Customizing drugs to cater to individual patients’ needs pursuant to a valid prescription on an as-prescribed basis. Problems arise when compounding pharmacies expand their practice beyond this traditional role. Some compounding pharmacies have, in effect, been performing as large-scale drug manufacturers without having to comply with the same strict FDA regulatory standards those manufacturers are subject to. These compounding pharmacies seem to be taking advantage of a loophole in the regulatory system.

Compounded drugs are altered versions of drugs that are FDA-approved. Compounded drugs themselves are not FDA-approved. An FDA-approved drug has been tested and approved in its specific form. When it is compounded, its composition is changed and whether its safety and efficacy remain intact becomes uncertain. For example, when drugs are merged together that have not been tested together, they may inactivate one another, there may be negative drug interactions, or they may degrade more quickly.

Because a compounding pharmacy is licensed by the board of pharmacy of the state in which it is located, that state has responsibility for its regulation, not the FDA. Generally, compounding pharmacies have not been required to register with the FDA. Thus, these pharmacies are not subject to FDA regulation; the FDA does not verify the quality, effectiveness, and safety of the compounded drugs being made, and these pharmacies do not have to tell the FDA what drugs they are making.

Without the FDA’s regulation and approval of compounding pharmacy drugs, the risk associated with compounded drugs increase. Compounded drugs made using unregulated, inferior compounding practices may be sub-potent, super potent, or dangerously contaminated. Without the FDA’s regulation and approval of the compounding pharmacies themselves, these pharmacies have been expanding their operations beyond their traditional roles, further escalating the risks associated with compounded drugs. This is evidenced by the increasing number of compounded drugs being recalled and the increasing number of compounding pharmacies being investigated by federal and state authorities.

It has been uncovered that many state-licensed compounding pharmacies are engaged in large-scale manufacture and distribution of unapproved new drugs, a practice that breaches the traditional compounding pharmacy role and crosses into drug manufacturing itself. Such"pharmacies" argue that these practices still fall within the traditional pharmaceutical role and are therefore exempt from FDA regulation. However, some of these pharmacies manufacture and distribute large amounts of unapproved drugs before receiving a valid prescription to be filled, without any need for the drugs to be altered, and produced for no particular patient’s needs. Because such practices are consistent with those of drug manufacturers and wholesalers, the practices should be subject to FDA regulation and enforcement.

What are the authorities doing to ensure public safety?

The FDA acknowledges the value of traditional pharmacy compounding and its importance to individual patient health.However, given the regulatory structure, some compounding pharmacies are able to engage in these unregulated drug manufacturing operations without being detected. This is especially true in instances where the drugs are ordered by and shipped directly to individual patient homes.

State licensing seemed to be the most efficient way to regulate compounding pharmacies until recently when compounding pharmacies were found to be responsible for contaminated drugs that caused serious infections, vision losses, and a deadly, widespread outbreak of fungal meningitis. These health threats drew the attention of the FDA, as it discovered that the once-clear line separating pharmacies from drug manufacturers had become blurred. It was discovered that some pharmacies were operating in states where they were unlicensed, shipping products in bulk to providers nationwide without a federal license, and specializing in mixing sterile products without adequate quality and safety controls.

Though the FDA recognizes that it will need more resources and power in the future to effectively identify and regulate compounding pharmacies that have expanded beyond their traditional role, the FDA pursued a quick course of investigation and inspection of questionable compounding pharmacies. The FDA has focused on those producing sterile drugs since they pose the greatest risk to public health. State responses have resulted in recalls, and state boards of pharmacies have revoked licenses and shut-down facilities when inspections have exposed unsafe practices and unsterile conditions. The discussion on how best to tackle the problem and compose effective regulations suited for compounding pharmacies continues.

How can you protect yourself?

There are many things that patients can do to protect themselves from the risk associated with taking compounded drugs. Asking specific questions of your healthcare provider and pharmacist may ensure your safety. Ask whether the drug your doctor has prescribed is compounded. If the drug is, in fact, compounded, ask where and why it is being compounded, and what possible side-effects and risks are involved in taking the compounded drug. Request an FDA-approved drug, if one is available. Ensure any compounded drug is being used according to your doctor and pharmacist’s directions and is properly stored. If you experience any signs or symptoms that are worrisome, call your healthcare provider or pharmacist immediately, and report any adverse reactions to the FDA.

Attorney Derek Merman of the Merman Law Firm is ready to represent the victims of negligent compounding pharmacy practices and is currently accepting client inquiries nationally. If you have taken a recalled compounded drug and have experienced an adverse reaction, contact the Merman Law Firm for a free consultation. If your case is accepted, you do not pay unless we win.

Derek is compassionate with his clients and passionate about his work for the injured and those that have lost loved-ones due to the negligence of others. Derek was raised by his mother on their ranch near Waco, Texas after his father died in a plane accident when he was six-years-old. As a result of that tragedy, Derek has devoted his practice to focusing on defective drugs and product injuries, wrongful-death claims, catastrophic injuries, and admiralty claims. Mr. Merman has helped his clients recover millions of dollars in verdicts and settlements during his career. Damages depend on the facts of the case, but in every circumstance, Derek endeavors to achieve high settlements and verdicts for each and every client.

Mr. Merman was the lead trial attorney on the Top Verdicts in Texas for civil rights in 2011 and co-lead for one of the Top Verdicts in Texas again in 2012. Mr. Merman is working on several cases that could compete for Top Verdicts in Texas again in 2013. To read more about Mr. Merman's results click here.

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